BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 4811385 · Received June 2, 2015

    Report

    Report Number
    2024168-2015-03098
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    April 4, 2015
    Report Date
    May 9, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SUTURE MEDIATED CLOSURE (SMC) SYSTEM WAS RETURNED FOR ANALYSIS. THE REPORTED SUTURE BREAK WAS CONFIRMED. IN ADDITION, ONE OF THE ANTERIOR CUFF TABS MEASURING ONE ONE-HUNDREDTH (0.01) OF AN INCH SQUARE WAS BROKEN OFF AND WAS NOT RETURNED WITH THE DEVICE. DUE TO THE EXTREMELY SMALL SIZE, A MISSING CUFF TAB IS NOT VISIBLE WITHOUT MAGNIFICATION AND WOULD NOT BE NOTED BY THE USER. BASED ON A VISUAL/FUNCTIONAL INSPECTION ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE WITH A 7F SHEATH AFTER AN INTERVENTIONAL ANEURYSM COILING PROCEDURE. REPORTEDLY, DURING PLUNGER RETRACTION, A SUTURE BREAK OCCURRED. HEMOSTASIS WAS ACHIEVED BY APPLYING MANUAL ARTERIAL COMPRESSION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354420 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 31114K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 7FHEPARIN